Abstract

Objective To evaluate the effectiveness of different brief intervention strategies at reducing hazardous or harmful drinking in primary care. The hypothesis was that more intensive intervention would result in a greater reduction in hazardous or harmful drinking.

Design Pragmatic cluster randomised controlled trial.

Setting Primary care practices in the north east and south east of England and in London.

Participants 3562 patients aged 18 or more routinely presenting in primary care, of whom 2991 (84.0%) were eligible to enter the trial: 900 (30.1%) screened positive for hazardous or harmful drinking and 756 (84.0%) received a brief intervention. The sample was predominantly male (62%) and white (92%), and 34% were current smokers.

Interventions Practices were randomised to three interventions, each of which built on the previous one: a patient information leaflet control group, five minutes of structured brief advice, and 20 minutes of brief lifestyle counselling. Delivery of the patient leaflet and brief advice occurred directly after screening and brief lifestyle counselling in a subsequent consultation.

Main outcome measures The primary outcome was patients’ self reported hazardous or harmful drinking status as measured by the alcohol use disorders identification test (AUDIT) at six months. A negative AUDIT result (score <8) indicated non-hazardous or non-harmful drinking. Secondary outcomes were a negative AUDIT result at 12 months, experience of alcohol related problems (alcohol problems questionnaire), health utility (EQ-5D), service utilisation, and patients’ motivation to change drinking behaviour (readiness to change) as measured by a modified readiness ruler.

Results Patient follow-up rates were 83% at six months (n=644) and 79% at 12 months (n=617). At both time points an intention to treat analysis found no significant differences in AUDIT negative status between the three interventions. Compared with the patient information leaflet group, the odds ratio of having a negative AUDIT result for brief advice was 0.85 (95% confidence interval 0.52 to 1.39) and for brief lifestyle counselling was 0.78 (0.48 to 1.25). A per protocol analysis confirmed these findings.

Conclusions All patients received simple feedback on their screening outcome. Beyond this input, however, evidence that brief advice or brief lifestyle counselling provided important additional benefit in reducing hazardous or harmful drinking compared with the patient information leaflet was lacking.

Footnotes

This paper is published on behalf of the SIPS programme research group. A full list of the research group members is available at http://sips.iop.kcl.ac.uk/contactus.php. We thank Ruth McGovern and Robert Patton for refining the study interventions and supporting the implementation of this trial.

Contributors: All of the authors contributed to the design and development of this trial protocol. CD was the chief investigator of SIPS and EK was deputy chief investigator and lead for the primary care trial. Expertise on clinical aspects of the research was provided for primary care by PC and JM, for nursing practice by TP and for psychiatry CD and EG. Statistical input was provided by SC, VD and MB. Health economics input was provided by CG and SP. Trial conduct and delivery expertise was provided by PD, DNB and KP. Alcohol and policy expertise was provided by AO and DS. Brief intervention expertise was provided by CD, EK, NH and JS. EK wrote the first draft of the paper and all authors contributed to successive drafts. All authors read and approved the final manuscript.

Funding: EK was part funded by Fuse the Centre for Translational Research in Public Health. Fuse is a UKCRC Public Health Research Centre of Excellence, and funding comes from the British Heart Foundation, Cancer Research UK, Economic and Social Research Council, Medical Research Council, and the National Institute for Health Research. This study was funded by the Department of Health. The views expressed herein do not necessarily reflect those of the Department of Health or the National Health Service in England and Wales.

Competing interests: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf (available on request from the corresponding author) and declare: all authors had financial support from the Department of Health in England (Alcohol Policy Unit) for the submitted work; no financial relationships with any organisations that might have an interest in the submitted work in the previous three years; no other relationships or activities that could appear to have influenced the submitted work.

Ethical approval: This study received multicentre ethical approval (06/MRE02/90) plus local agreement from all relevant local research ethics committees. Research governance approval was granted by all relevant primary care trusts. The research was done in accordance with the Helsinki declaration.